Provera (Medroxyprogesterone acetate)
Provera 100mg Tablet
Provera 200mg Tablet
Provera 400mg Tablet
(Medroxyprogesterone acetate)
1. What Provera Tablets are and what they are used for
Provera Tablets belong to a group of medicines called ‘Progestogens’. Progestogens act like progesterone, a natural sex hormone
Provera Tablets contain the progestogen called medroxyprogesterone acetate.
Medroxyprogesterone acetate can slow down the growth of certain tumours which are sensitive to hormones
Provera tablets are used in the treatment of cancer in the breast, kidney (in men and women) and in the lining of the womb (endometrial cancer). It is also used to treat cancer which has spread to other parts of the body (metastatic cancer) in post menopausal women (women who have stopped having their periods)
It is not expected that Provera will be used in children for the above indications. If you are not certain why you are being given this medicine, ask your doctor.
2. Before you take Provera Tablets
Do not use Provera Tablets if you have the following conditions:
hypersensitivity (allergy) to Provera tablets or other similar hormone medicines or any of the other ingredients in Provera.
liver problems
A heart condition where you feel pain in your chest when you exert yourself (angina) or have had a heart attack or if you have been told that you are at risk of developing cardiovascular diseases raised levels of calcium in the blood (hypercalcaemia) in patients with metastasised bone cancer suspected or recently diagnosed breast cancer for the first time undiagnosed vaginal bleeding past or recent blood clot disorders, including deep vein thrombosis (DVT), pulmonary embolitis, thrombophelbitis (inflammation of the blood vessels) or if you have been told that you are at risk of developing these conditions a history of a condition known as porphyria ( an hereditary blood disorder) missed abortion (where the woman’s body does not expel the dead foetus), miscarriage or pregnancy
Take special care with Provera Tablets:
Tell your doctor if you have any of the following conditions to help him or her decide if Provera is suitable for you:
- fluid retention
- diseases that affect the heart and blood vessels (cardiovascular disease)
- epilepsy
- migraine headaches
- sudden vision disturbance
- asthma
- liver or kidney problems
- diabetes
- depression or a history of depression
- hyperlipidaemia (raised levels of fat in the blood)
if you are taking or have recently taken any other medicines, even those not prescribed
jaundice (a condition which causes the skin or whites of the eye to appear yellow)
a significant increase in high blood pressure
Risk of Venous Thromboembolism (VTE)
All women have a small chance of having a blood clot in the veins of the leg, in the lung or other parts of the body. The chances of getting a clot are very slightly increased if you are taking a hormone medicine like Provera. You are more likely to get a clot whether or not you are taking Provera if you-
- are very overweight
- have relatives who have had blood clots
- have had a blood clot in the veins or lungs before
- are unable to move for long periods of time (for example after an operation)
- have a serious injury or have major surgery.
- have a history of repeated miscarriage
Tell your doctor if you have just had an operation or if you are going to have an operation while taking Provera.
Treatment with Provera Tablets may cause you to have symptoms associated with Cushings Syndrome.
Taking other medicines:
Some drugs may affect the action of Provera tablets in your body. Tell your doctor or pharmacist if you are taking:
- anticonvulsants like phenobarbitol, phenytoin, carbamezapine for epilepsy (fits)
- anti-infective medicines like rifampicin, rifabutin, efavirenz or nevirapine for infections caused by
- bacteria and yeast
- cytotoxics drugs (drugs that kill cancerous cells)
- ciclosporin for suppressing the immune system
- herbal preparations containing St. John’s Wort
- aminogluthemide sometimes used in Cushings syndrome
- anticoagulants like warfarin for thinning the blood
- Pain killers like aspirin, ibuprofen or naproxen and vasodilators like hydrazalazine, minoxidil may affect the way Provera Tablets work. Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription
Pregnancy
Avoid becoming pregnant while being treated with Provera. Provera must not be taken if you are pregnant as hormonal medicines may affect the developing baby. Tell your doctor if you are pregnant, had an abortion or missed a period during treatment. Your doctor may give you a pregnancy test before starting treatment. If you are sexually active, you are advised to use effective birth control to prevent pregnancy while taking Provera.
Breast feeding
You should stop breast feeding before starting treatment with Provera as this medicine may be harmful to infants being breast-fed.
Ask your doctor or pharmacist for advice before taking any medicine while breast feeding.
Driving and using machinery
There are no special precautions, and you can drive or operate machinery as long as you feel well and able to do so.
Laboratory Tests:
Please inform your doctor if you need to have any blood tests or gynaecological assessment, as Provera may affect their results
3. How to take Provera Tablets
You will be closely monitored and regularly assessed before and during your treatment with Provera, especially if you are prescribed large doses of the tablet.
Cancer of the Endometrium (womb lining) and Kidney:
The usual dose is 200mg to 600mg a day. Breast Cancer:
The usual dose is 400mg to 1500mg a day. The chance of having a minor side effect, such as indigestion and weight gain, increase as the dose increases.
Swallow each tablet whole. Take your tablets at the same time each day. Follow your doctors instructions. These can be found in the label of your pack. If you are not sure ask your doctor.
Treatment may be required for 8 to 10 weeks before any effect can be found.
If you take too many tablets
If you take too many Provera tablets, contact your doctor straight away.
If you forget to take a dose of Provera tablets
If you forget to take your dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines Provera can cause some side effects. If they occur, they are most likely to be minor and temporary. If you get any of the symptoms mentioned below, you should stop taking the tablets and see your doctor immediately. These could all be warning signs of thrombosis (a blood clot) which will need urgent treatment.
Reasons for seeking immediate medical advice
• Rarely, Provera may cause a severe allergic reaction which can be life-threatening in some cases. If you think you are reacting badly to the medicine get emergency medical help immediately. The symptoms of an allergic reaction could be the following: wheezing, difficulty breathing, feeling faint, swelling of the face or tongue, hands and feet, intense itchy skin rash.
• There have also been reported cases of raised blood calcium levels (hypercalcaemia) in patients with breast cancer. Please report any unusual vaginal bleeding, loss of vision or if there is a sudden onset of enlarged eyeball, double vision or migraine.
These are symptoms of a blood clot in the lungs which may all occur together: Sudden, severe, sharp pain in your chest Coughing up blood You suddenly become short of breath Your heart beats more rapidly
These can be symptoms of a blood clot in the brain (‘a stroke’)
You have an unusually severe or long headache Your sight is affected in any way
You find it difficult to speak
You collapse or faint
Any part of your body feels weak or numb or cannot move
These are symptoms of a deep-vein thrombosis (DVT).
You have pain, tenderness or swelling in your calf, ankle or foot
You have purple discolouration of the skin of the leg or the skin becomes red and warm to touch
Reasons for stopping Provera Tablets immediately
Your treatment will be discontinued if you have any of the following symptoms: yellowing of the skin or whites of the eyes or liver problems a significant increase in blood pressure new onset of migraine-type headache
Other Side effects reported with Provera Tablets include the following:
- Effects on the reproductive system and breasts: breast pain and tenderness, a milky discharge from the breast when not pregnant or breastfeeding, unexpected or unusual vaginal bleeding or spotting, the stopping or extended break of your periods and vaginal discharge.
- Effects on your central nervous system: confusion, euphoria (a state of extreme well-being and pleasure), loss of concentration, nervousness, difficulty sleeping, drowsiness, tiredness ,dizziness, depression, vision disorders, and headache.
- Effects on your digestive system: Constipation, diarrhoea, dry mouth, yellowing of the skin or whites of the eyes, feeling sick and indigestion.
- Effects on your heart and circulation: blood clots, including clots in the lung, swelling in the veins due to blood clots, stroke, heart attacks, the sensation of feeling your heartbeat and may effect certain blood test (causing raised white blood cells).
- Effects on your skin, nose, throat or hair: sensitivity reactions ranging from itchy skin, nettle rash or hives, swelling in face/throat which may cause difficulty breathing to a general rash and severe allergic reactions. There have been cases of acne and hair loss or facial hair growth reported.
- Effect on your metabolism: lack of appetite, feeling thirsty, ,effects like fine hand tremors, sweating, tremors, cramps in calves at night, Cushingoid Syndrome, decreased sugar tolerance, cloudy vision, an increase in your symptoms of diabetes mellitus and may effect both blood and urine tests.
When you are being given Provera, if you feel any change in appetite, change in libido (sex drive), fluid retention, weight gain, tiredness, high fevers, or facial swelling, you must tell your doctor.
If you experience any of the above side effects or notice any other unusual effects not mentioned in the leaflet, tell your doctor at once.
5. How to store Provera Tablets
The unopened bottles should be stored in the original container until ready for use.
Do not store above 25°C.
Keep out of the reach and sight of children.
Provera should not be used after the expiry date printed on the box and on the bottle label.
6. Further Information
- What Provera tablets contains
Each Provera Tablet contains either 100mg, 200mg or 400mg of the active ingredient medroxyprogesterone acetate.
- What Provera tablets look like and contents of the pack
Provera Tablets are available in the following pack sizes: Provera Tablets 100mg: 60 and 100 tablets in blister strips; Provera Tablets 200mg: 30 and 100 tablets in blister strips; Provera Tablets 400mg: 30 tablets in blister strips.
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